EUCTR2010-023129-39-DE进行中（未招募）不适用
A multi-center, randomized, double-blind, controlled study to evaluate the safety and efficacy of MP4OX treatment, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Informed consent obtained before any study-related activities (study-related activities are any procedure that would not have been performed as standard of care for the patient)
- •2)Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock
- •3)Acidosis (blood lactate level = 5 mmol/L; equivalent to 45 mg/dL) arterial or venous
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1)Massive injury incompatible with life
- •2)Normalization of lactate prior to dosing (= 2.2mmol/L)
- •3)Patients with evidence of severe traumatic brain injury as defined by ANY one of the following:
- •a)Known non-survivable head injury or open brain injury
- •b)Glasgow Coma Score (GCS) = 3, 4 or 5
- •c)Known AIS (head region) = 4 shown by an appropriate imaging methodology
- •d)Contemplated CNS surgery (NOTE: insertion of an intra-cranial pressure device is not considered CNS surgery)
- •e)Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level
- •NOTE: Patients with a GCS of less than 6 at the time of enrollment may be enrolled, but it is expected that if they are enrolled, they will clearly meet all of the following conditions:
- •- Documented GCS of 6 or greater at the scene
- •- No physical evidence of head injury at the scene
- •- No evidence of brain injury by appropriate imaging techniques at the hospital
- •- The patient is intubated and sedated and the depressed GCS can be reasonably be attributed to the sedation given to perform or maintain intubation
- •- No other exclusionary neurological conditions (such as high spinal cord injury etc)
- •4)Cardiac arrest prior to randomization
- •5)Age below the legal age for consenting
- •6)Estimated time from injury to randomization> 4 hours
- •7)Estimated time from hospital admission to randomization > 2 hours
- •8)Known pregnancy
- •9)Use of any oxygen carrier other than RBCs
- •10)Known previous participation in this study
- •11)Professional or ancillary personnel involved with this study
- •12)Known receipt of any investigational drug(s) within 30 days prior to study
研究者
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